Erecta Tablet - Renata Limited

KxuPcjJKlu
Sildenafil
Presentation
Erecta® 50mg Tablet
Erecta® 100mg Tablet
: Each tablet contains Sildenafil Citrate INN equivalent to Sildenafil
50mg.
: Each tablet contains Sildenafil Citrate INN equivalent to Sildenafil
100mg.
Description
Erecta® is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate
(cGMP)-specific phosphodiesterase type 5 (PDE5).
Pharmacology
Erecta® works by helping to relax the blood vessles of penis. The physiologic mechanism of erection of the
penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then
activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine
monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing
inflow of blood. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but
enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is
responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local
release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum,
resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at
recommended doses has no effect in the absence of sexual stimulation.
Indication
Erecta® is indicated for treatment of Erectile Dysfunction.
Dosage & Administration
The usual dose of Erecta® is 50mg once daily. It should be taken before 30-40 minutes of intercourse.
Depending of effectiveness & tolerance, the dose may be increased to a maximum recomended dose of
100mg or decreased to 25mg. The maximum dosing frequency is once per day. Some factors are
associated with increased plasma levels of sildenafil: age more then 65 years, hepatic problem, severe
renal impairment and concomitant use of ketoconazole, itraconazole, erythromycin. Since higher plasma
levels may increase both the efficacy and incidence of adverse events, a starting dose of 25mg should be
considered in these patients. Erecta® may take longer time to work if it is taken with a heavy meal.
Contraindications
Erecta® was shown to potentiate the hypotensive effects of nitrates, and its administration to patients
who are using organic nitrates, either regularly and/or intermittently, in any form is therefore
contraindicated.
Side effects
The side effects reported in association with the use of Sildenafil are usually mild to moderate and a short
duration. Sildenafil can cause allergic reactions. Contact with doctors immediately if experiences any of
the following symptoms: difficulty in breathing or dizziness, swelling of the eyelids,face,lips or throat.
Common side effects include headache,indigestion,light sensitivity, blurred vision. Uncommon side
effects include vomiting, skin rash, bleeding at the back of the eye, red eyes, eye pain, double vision,
irregular or rapid heartbeat,muscle pain,feeling sleepy,vertigo,nausea, dry mouth, chest pain and feeling
tired.
Warnings
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular
disease. Therefore, treatments for erectile dysfunction, including Erecta® , should not be
generally used in men for whom sexual activity is inadvisable because of their underlying
cardiovascular status.
Erecta® has systemic vasodilatory properties that resulted in transient decreases in supine blood
pressure. , before prescribing Erecta®, physicians should carefully consider whether their patients with
underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in
combination with sexual activity.
There is no controlled clinical data on the safety or efficacy of Erecta® in the following groups;
if prescribed, this should be done with caution.
Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia
within the last 6 months;
Patients with resting hypotension (BP <90/50) or hypertension (BP >170/110)
Patients with cardiac failure or coronary artery disease causing unstable angina
Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of
retinal phosphodiesterases)
Patients with sickle cell or related anemias
Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in
duration) have been reported infrequently since market approval of Erecta®. In the event of an
erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
Precautions
Before prescribing Erecta®, it is important to note the followings:
Caution is advised when Phosphodiesterase Type 5 (PDE5) inhibitors are co-administered with
alpha-blockers. PDE5 inhibitors, including Erecta®, and alpha-adrenergic blocking agents are
both vasodilators with blood pressure lowering effects. When vasodilators are used in
combination, an additive effect on blood pressure may be anticipated. In some patients,
concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic
hypotension (e.g. dizziness, fainting).
Consideration should be given to the following:
Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.
Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at
increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be
initiated at the lowest dose.
In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should
be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with
further lowering of blood pressure when taking a PDE5 inhibitor.
Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other
variables, including intravascular volume depletion and other anti-hypertensive drugs.
Erecta® has systemic vasodilatory properties and may augment the blood pressure
lowering effect of other anti-hypertensive medications.
Overdosage
In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to
those seen at lower doses but incidence rates and severities were increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not
expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in
the urine.
Pregnancy, Lactation & Paediatric Use
Erecta® is not indicated for newborns, children & women.
Storage
Store in a cool and dry place, away from light and children.
Packaging
Erecta® 50mg Tablet: Each box contains 1x4’s tablets in alu-alu blister.
Erecta® 100mg Tablet: Each box contains 1x4’s tablets in alu-alu blister.
®
Trademark
Manufactured by
RENATA LIMITED
Mirpur, Dhaka, Bangladesh
CkJhJj„
APrTaJ® 50 aqJmPua„ k´KfKa Kluì ßTJPac aqJmPuPa IJPZ 50 Ko.V´J. KxuPcjJKlu xJAPasa
IJAFjFj KyPxPmÇ
APrTaJ® 100 aqJmPua„ k´KfKa Kluì ßTJPac aqJmPuPa IJPZ 100 Ko.V´J. KxuPcjJKlu xJAPasa
IJAFjFj KyPxPmÇ
metjJ„
APrTaJ® FTKa KxuPcjJKlPur xJAPassa umj, pJ lxPlJcJAFˆJPr\ aJAk-5 mJ KkKcA-5
AjKyKmarx V´∆Pkr FTKa HwiÇ
lJotJPTJuK\„
APrTaJ® KuPñr rÜjJuLPT KvgLu TrJr oJiqPo TJ\ TPrÇ ßpRj C¨LkjJr xo~ KuPñr
jJAKasT IéJAc, è~JjJAPua xJAKTîP~\ Fj\JAoPT C¨L¬ TPr, oxOj oJÄxPkvLPT KvgLu
TPr FmÄ KuPñ rÜ k´PmPv xJyJpq TPrÇ pUj ßpRj C¨LkjJr lPu ˙JjL~nJPm jJAKasT IéJAc
oMÜ y~, KxuPcjJKlu KkKcA-5 ßT hoPjr oJiqPo TktJx TqJnJrPjJxJPo -Fr kKroJj mJKz~
Ph~, pJr lPu oxOj oJÄxPkvL KvgLu y~ FmÄ TktJx TqJnJrPjJxJPo rÜ k´mJKyf y~Ç ßpRj
C¨LkjJr IjMkK˙KfPf KxuPcjJKlu KjPhtKvf oJ©J~ TJ\ TPr jJÇ
KjPhtvjJ„
APrTaJ® KuPñr C™JPj IãofJ IgmJ i±\nPñr KYKT&xJ~ KjPhtKvfÇ
PxmjKmKi S oJ©J„
APrTaJ® xJiJrjf 50 Ko.V´J. KhPj 1 mJr ßpRj KouPjr 30-40 KoKja kNPmt ßxmj Trf yPmÇ
TJptTJKrfJ S xyjL~fJr Ckr KnK• TPr oJ©J xPmtJóY 100 Ko.V´J. kpt∂ mOK≠ TrJ ßpPf kJPr
IgmJ 25 Ko.V´J. kpt∂ ToJPjJ ßpPf kJPrÇ xPmtJóY KhPj FTmJr Hwi ßxmj TrJ CKYfÇ KTZá
KTZá TJrPj rPÜ KxuPcjJKlu Fr kKroJj ßmPz ßpPf kJPr, ßpoj-m~x 65-Fr ßmKv yPu,
pTíPfr ITJptTJKrfJ, mOÑL~ ITJptTJKrfJ FmÄ KTPaJPTJjJ\u, A≤sJPTJjJ\u,
ArJAPgsJoJAKxj-Fr pMVk& mqmyJrÇ APrTaJ® nrJ ßkPa ßxmj TrPu TJptTJKrfJ Êr∆ yPf KmuÍ
yPf kJPrÇ
k´KfKjPhtvjJ„
pJrJ jJAPasa \JfL~ SwMi Kj~Kof mJ IKj~Kof ßxmj TrPZj, KxuPcjJKlu fJPhr \jq
KjPhtKvf j~, TJrj KxuPcjJKlu rÜYJk TKoP~ KhPf kJPrÇ
kJvõtk´KfKâ~J„
KxuPcjJKlu mqmyJPrr kJvõt k´KfKâ~J oOhM ßgPT oiqo FmÄ ˝· ˙J~LÇ Ijq xTu HwMPir ofA
KxuPcjJKluS FuJK\tr TJrj yPf kJPr ßpoj-fJ&ãKjT ÉAK\Ä, võJxTÓ, ßYJPUr kJfJ,
oMUo¥u, ßbÅJa S VuJ láPu pJS~JÇ xJiJrj kJvõt-k´KfKâ~Jr oPiq IJPZ-oJgJ mqgJ, oMU¥u
\ôJuJPkJzJ TrJ, mhy\o, ^JkxJ hOKÓ, oJgJ ßWJrJ FmÄ IJPuJT xÄPmhjvLufJ, hMutn
kJvõtk´KfKâ~Jr oPiq rP~PZ- mKo, ßYJPUr KkZPj rÜrãe, rÜuJu ßYJU, fôPTr láÅxTáKz, ßYJU
mqgJ, ßYJPU hMPaJ ßhUJ, hs∆f Âh¸ªj, oJÄxPkvLPf mqgJ, WMoWMonJm, TJPj v» yS~J, oMPU
ÊÛJjMnëKf, mMPT mqgJ, TîJK∂ IjMnëKfÇ
xfTtfJ„
KxuPcjJKlu xJiJrjf KTZá Hwi KmPvw TPr mMPTr mqgJ~ mqmÂf HwMi xoNPyr xJPg
k´KfmºTfJ ‰frL TrPf kJPrÇ \r∆rL Im˙J~ cJÜJPrr krJovt Kjj FmÄ KxuPcjJKlu ßxmj
ßgPT Kmrf gJTPf yPmÇ jJAPasa \JfL~ HwMi mqmyJr TrPu KxuPcjJKlu mqmyJr TrJ pJPm
jJÇ FjK\jJ ßkTPaJKrxJ mJ mMPTr mqgJ~ mqmÂf HwMi mqmyJr TrPu xmthJ IJkjJr cJÜJr mJ
lJotJKxˆPT ImKyf Tr∆jÇ ßp xo˜ ßrJVLrJ CóY rÜYJPkr KYKT&xJ~ mJ ßk´JPˆa mOK≠r
KYKT&xJ~ IJulJ mäTJr ßgrJKk ßj~ fJPhr ßãP© oJgJ ßWJrJ mJ oJgJ yJuTJ IjMnNKfr oPj yPf
kJPrÇ Fxm uãjèPuJr x÷mJmqfJ ToJPf yPu KxuPcjJKlu Êr∆ TrJr kNPmt IJulJ mäTJr-Fr
Kj~o S k´JfqKyT ßxmjoJ©J KjKhtÓ TrPf yPmÇ HwMi ßgPT CkTJKrfJ ßkPf yPu KxuPcjJKlu
ßxmPjr kNPmt IKfKrÜ IqJuPTJyu kJj TrJ pJPm jJÇ
IKfoJ©J„
krLãJ~ ßhUJ ßVPZ xM˙ ßxóZJPxmLPhr ßãP© 800 Ko.V´J. Fr ßmvL FTT oJ©J~ KhPu ßp
kJvõtk´KfKâ~J ßhUJ pJ~ fJ To oJ©Jr k´KfKâ~Jr oPfJAÇ IKfoJ©Jr ßãP© hs∆f mqm˙J V´ye
TrPf yPmÇ KxuPcjJKlu käJ\oJ ßk´JKaPjr xJPg UMm ßmvL kKroJPj pMÜ y~ FmÄ k´xsJPmr xJPg
To KjVtf y~ mPu cJ~JuJAKxPxr oJiqPo IkxJrj UMm ßmvL x÷m j~Ç
VntJm˙J~, ˜jqhJjTJPu S KvÊPhr ßãP© mqmyJr„
APrTaJ® jm\JfT, KvÊ S oKyuJPhr ßãP© KjPhtKvf j~Ç
xÄrãj„
300 ßx. fJkoJ©Jr jLPY, IJPuJ S IJhstfJ ßgPT hNPr rJUMjÇ KvÊPhr jJVJPur mJAPr rJUMjÇ
xrmrJy„
APrTaJ® 50 aqJmPua„ k´KfKa mJPé IJPZ 4Ka aqJmPuaÇ
APrTaJ® 100 aqJmPua„ k´KfKa mJPé IJPZ 4KKa aqJmPuaÇ
®
Trademark
k´˜áfTJrT„
ßrjJaJ KuKoPac
KorkMr, dJTJ, mJÄuJPhv